NCT00405496

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Sirion Therapeutics, Inc. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

Detailed description

The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution. The secondary objective was to establish the evaluation system for a dose-finding study.

Conditions

• Anterior Uveitis

Interventions

Type	Name	Description
DRUG	Difluprednate Ophthalmic Emulsion

Timeline

• Start date: 2000-03-01
• Completion: 2001-04-01
• First posted: 2006-11-30
• Last updated: 2006-11-30